nvCJD statistics to 31 May 1999: official toll reaches 44

Comment (webmaster):
It seems DoH will no longer making the table available online as of this month. The table will be sent only to selected journalists. It is unlikely that newspapers will print the table. The GSS, iatrogenic, and familial CJD data may appear in the annual SEAC report.

Note the nomenclatural struggle in #2 to wipe out nvCJD in favor of vCJD. Note vCJD seems litle used ouside of SEAC; there are too many variants of CJD reported each month for 'variant CJD' to be workable.

To 31 May 1999, the total number of definite and probable cases of nvCJD = 42, thus two new cases are reported for the month of May. This would not include the Irish and French cases, bringing the official confirmed total to 44.

There is no explanation posted for sporadic CJD and total CJD having plunged to 28% of rates in former years, along with a 33% drop in reported referrals following closely upon the press release stating a 33% increase in referrals was expected for 1999.
5 JULY 1999

MONTHLY CREUTZFELDT-JAKOB DISEASE FIGURES

The Department of Health is today issuing the latest monthly table, giving the numbers of deaths of definite and probable cases of Creutzfeldt-Jakob disease in the UK.

NOTE: TABLES ON HARD COPY ONLY.

* To 31 May 1999. Total number of definite and probable cases of vCJD = 42.

1. The next table will be published on Monday 2 August 1999.

2. At its meeting on 18 March 1999 the Spongiform Encephalopathy Advisory Committee (SEAC) agreed that variant CJD (vCJD) should now be used in preference to nvCJD in line with current practice in many scientific journals.

Referrals: This is a simple count of all the cases which have been referred to the National CJD Surveillance Unit for further investigation in the year in question. CJD may be no more than suspected; about half the cases referred in the past have turned out not to be CJD. Cases are notified to the Unit from a variety of sources including neurologists, neuropathologists, neurophysiologists, general physicians, psychiatrists, electroencephalogram (EEG) departments etc. As a safety net, death certificates coded under the specific rubrics 046.1 and 331.9 in the 9th ICD Revisions are obtained from the Office for National Statistics in England and Wales, the General Register Office for Scotland and the General Register Office for Northern Ireland.

Deaths: These columns show the number of deaths which have occurred in definite and probable cases of all types of CJD and GSS in the year shown. The figure includes both cases referred to the Unit for investigation while the patient was still alive and those where CJD was only discovered post mortem (including a few cases picked up by the Unit from death certificates). There is therefore no read across from these columns to the referrals column. The figures will be subject to retrospective adjustment as diagnoses are confirmed.

Definite and Probable: This refers to the diagnostic status of cases. In definite cases the diagnosis will have been pathologically confirmed, in most cases by post mortem examination of brain tissue (rarely it may be possible to establish a definite diagnosis by brain biopsy while the patient is still alive). Probable cases have not been confirmed pathologically; some cases are never confirmed pathologically because a post mortem examination does not take place (for instance where the relatives of the patient refuse consent) and these cases remain permanently in the probable category.

Sporadic: Classic CJD cases with typical EEG and brain pathology. Sporadic cases appear to occur spontaneously with no identifiable cause and account for 85% of all cases.

Probable sporadic: Cases with a history of rapidly progressive dementia, typical EEG and at least two of the following clinical features; myoclonus, visual or cerebellar signs, pyramidal/extrapyramidal signs or akinetic mutism.

Definite nvCJD cases still alive: These will be cases where the diagnosis has been pathologically confirmed (by brain biopsy).

Probable nvCJD: Cases in which post-mortem (or brain biopsy) has not been carried out and which fulfil preliminary criteria for the clinical diagnosis of nvCJD. These criteria cannot yet be fully validated because of the limited experience of nvCJD.

Warning of major CJD epidemc

Prof John Collinge of St Mary's Hospital, London, a member of the Government's Spongiform Encephalopathy Advisory Committee, was cited as writing in the Lancet Friday that a major epidemic of new variant CJD remains a strong possibility (see below).

He greets the recent optimism that the human BSE epidemic may be levelling out with caution, given that it has been only three years since new variant CJD was recognised. Prof Collinge is pessimistic because he estimates the incubation time for the disease - the time between infection with BSE and the development of the devastating brain disease CJD - is probably a matter of decades rather than years. Studies of related spongiform diseases, such as kuru, suggest incubation periods of up to 40 years.

New Variant Creutzfeldt-Jakob Disease

July 24, 1999 Lancet 1999; 354: 317-23
John Collinge MRC Prion Unit and Department of Neurogenetics, Imperial College School of Medicine at St Mary's

It is clear that the prion strain causing bovine spongiform encephalopathy (BSE) in cattle has infected human beings, manifesting itself as a novel human prion disease, variant Creutzfeldt-Jakob disease (CjD). Studies of the incubation periods seen in previous epidemics of human prion disease and of the effect of transmission barriers limiting spread of these diseases between species, suggest that the early variant CJD cases may have been exposed during the preclinical phase of the BSE epidemic.

It must therefore be considered that many cases may follow from later exposure in an epidemic that would be expected to evolve over decades. Since the number of people currently incubating this disease is unknown, there are concerns that prions might be transmitted iatrogenically via blood transfusion, tissue donation, and, since prions resist routine sterilisation, contamination of surgical instruments. Such risks remain unquantified.

Although variant CJD can be diagnosed during life by tonsil biopsy, a prion-specific blood test is needed to assess and manage this potential threat to public health. The theoretical possibility that BSE prions might have transferred to other species and continue to present a risk to human health cannot be excluded at present.

Sensitive diagnostic
methods will be required not only for large-scale prevalence studies of
preclinical variant CJD and to exclude blood and other tissue and organ
donations from preclinical cases, but also to be able to reassure the
"worried well". The earliest symptoms of variant CJD are ill-defined
peripheral sensory disturbances, depression, and anxiety, and clear evidence
of an emerging epidemic of variant CJD might lead many to seek medical
advice and reassurance.

Comment (webmaster): This long Lancet review article reveals very little of what Collinge must know about the current extent of the nvCJD epidemic. His lab began looking at tonsils many months ago from both unconfirmed cases of nvCJD and from the bank of tonsils routinely saved after removal. Many thousands of tonsils must have been examined by the end of 1998 yet there is no disclosure. It hardly seems possible that he would be unaware of MJ Schmerr's successful technique for detecting rogue prion in mammalian blood or of recent developments at Rocky Mtn lab with in vitro conversion. The article ends with an ominous tilt towards suggesting that the real problem is with the worried well and that this somehow justifies non-disclosure of what insiders know about the extent of the epidemic.

New BSE chronology

1935 Edinburgh, Moredun

Louping-ill vaccine disaster. This was to
eventually demonstrate several extremely important points. Apparently
healthy young sheep brains, still in the early preclinical stages
harboured the disease agent in sufficient quantities, that when the
vaccine formed from eight or less brains was given to 18000 sheep, it
infecting many thousands of sheep in Scottish flocks, some flocks
previously free of the disease. Demonstrated the disease agent's
incredible resistance to destruction by formalin.
...

1970's UK

Industrial processing of cow and sheep heads made viable by
crushing and centrifuging to maximise extraction of tissue, brain,
eyeballs, etc. to maximise the product used in pies, burgers and
sausages for human consumption. This product was also used in the
suspect animal feed. Processing sheeps heads made viable for first
time.
...

July, 1985 BBC

Knowledge of a new cattle brain disease brought into the
public arena by a single BBC TV news story followed by a anonymous
categorical denial that it posed a threat to people that it posed a
health hazard to the human population. Official Government policy of
dissembling and lying about the risk to the population appears to be
initiated at this early date. No concrete positive action taken.

November,1986 UK

UK Health Ministry because of risk of the new disease
stops the use of bovine membranes for dura mater "repairs" in human
brain operations.

Easter, 1988

Washington orders USAF Europe to stop the contract with
Frans Buitelaar, Boston, England for the supply of British origin
processed beef products. USAF Europe then supplied direct from USA
with processed beef products to avoid health risk. "Contract records
destroyed after six years". [British meat itself continued to be supplied until April, 1996 -- webmaster]

CDC swipes money meant for chronic fatigue

Federal researchers assured lawmakers they would investigate the mysterious disease, then used millions to study other illnesses. At least $8.8 million, 39 percent of the funds earmarked for CFS, was spent on other research, including measles and polio. Government auditors say they cannot determine what happened to an additional $4.1 million.

Activists say some officials at the Centers for Disease Control and Prevention don't believe CFS is a real disease, never intended to study it and merely paid lip service to the malady in testimony to lawmakers pressing for action. "It's been amazing with the CDC how much some of the scientists are concerned more about politics than science. They want to protect their careers. That's why they put forth the token effort," asserts Kim Kenney, executive director of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America.

Patients diagnosed with CFS say they become so tired they can't perform even the simplest tasks. One sufferer, Michelle Akers, a star on the U.S. women's soccer team for more than a decade and now playing in the World Cup, is sometimes unable to work out with the team and often plays only half a game. The symptoms of CFS -- muscle and joint pain, headaches and memory loss -- are difficult to measure, and attempts to pinpoint its cause have failed.

Much like Gulf War Syndrome, CFS is not completely understood by the health community, and it's usually diagnosed by ruling out other problems. Researchers are sometimes reluctant to accept diseases characterized by such elusive symptoms, acknowledges Dr. Peter Rowe, director of the Chronic Fatigue Clinic at the Johns Hopkins Children's Center in Baltimore. "Lupus is an example. It wasn't until better blood testing that recognition improved."

The CDC's alleged misappropriation of funds came to light last year when a researcher in the department assigned to CFS blew the whistle. An audit released May 10 by the inspector general for the Department of Health and Human Services confirmed his allegations.

"CDC officials provided inaccurate and potentially misleading information to Congress concerning the scope and cost of CFS research activities," the audit says. Although the CDC was not legally prohibited from using CFS funds elsewhere, agencies tend to follow Congress' recommendations to avoid offending the lawmakers who control their budgets.

That may be where part of the problem lies, some say. "Most politicians aren't very smart researchers, and most researchers aren't very smart politicians, so you've got a real dilemma," says Dr. John Renner, president of the National Council for Reliable Health Information. "Spending money wisely is what's got to be done."

In his complaint to Congress, Dr. William Reeves, a branch chief in the CDC's National Center for Infectious Diseases, accused Dr. Claire Broome, then-acting CDC director, of providing false information to Congress when she testified that part of the 1996 CFS research money was spent on a new laboratory in Reeves' department. No such laboratory was built. Reeves also said the division director, Dr. Brian Mahy, transferred funds from the CFS program to research areas he deemed more important.
Mahy has refused to comment.

Rep. John Porter, R-Ill., chairman of the subcommittee that handles the CDC budget, says the problem is not that chronic fatigue money was used for other research, but that CDC officials lied about it. "I have no problem if they had come back to us and said look, they don't think there is any good research we can follow here, this is not good use of the money," Porter says.

Renner, however, notes that researchers are under pressure to appease lawmakers. If a CDC official told Congress that CFS was not worthy of research, he says, "they probably would have shot the guy the next day at sunrise out in front of the Capitol building."

Porter acknowledges the political pressure on researchers but says it is sometimes justified. "CDC is a publicly funded institution of the government and it has to respond to some degree to the concerns of the people of this country, and those people are represented in Congress," he says.

In response to the audit, CDC director Jeffrey Koplan says the agency will share a CFS spending plan with Congress and nonprofit groups and add training for budget managers and staff. The CDC denies the funding diversions arose from a lack of interest in chronic fatigue syndrome, says spokeswoman Barbara Reynolds. "It was a lot more a question of the accounting of the ways the funds were spent as opposed to diverting the funds," she says.

But Reeves, the whistle blower, scoffs at the idea the problem lay with poor accounting. For more than a year, he says, he internally reported the diversion of funds and was "basically told to shut up."

Renner, whose Reliable Health Information council tracks medical fraud and misinformation, calls chronic fatigue syndrome "an illness that has brought out the worst medical politics." CFS is "something we don't understand yet," he says. "We have to be very, very cautious about how research money is going to be spent."

Comment (webmaster):
CDC is an extremely political organization with strong biases towards diseases already having powerful internal lobby groups in place. Perjury in congressional however goes beyond politics to an ethical breach. The lesson here is that even if family activist groups succeed in raising awareness in Congress towards CJD, extra funds would just be diverted to less inconvenient diseases. It would be far better for extra funds to go to a more science-based entity such as NIH.

Mass cull of calves forecast

July 6 1999 L. Times

THOUSANDS of calves are facing slaughter after Nick Brown, the
Agriculture Minister, announced the end of a £47 calf subsidy.
The payment was established three years ago to compensate farmers for
the ban on beef exports to EU states and the ban on live calf exports for
the continental veal market.

Mr Brown confirmed yesterday that it would cease at the end of the
month.
The National Farmers Union had been banking on an extension, but Mr
Brown said he had already won two from the Treasury. "I can do no
more," he said.

By the end of the month some two million calves will have been
slaughtered under the subsidy scheme.
Without a commercial market, it is too costly for farmers to rear
calves. Animal welfare groups fear that they will choose to kill them,
perhaps inhumanely to save on abattoir costs.

The Meat and Livestock Commission this week advised farmers to
identify new markets for their veal before deciding to rear calves. It
believes that it will be possible for some farmers to make a living and
that they should target British food manufacturers who are currently
importing processed beef from abroad.Another option would be for
farmers to sell the meat as pet food.

With the EU ban on beef exports expected to be lifted within weeks,
farmers might also be able to export veal.
The commission does not believe that veal consumption in Britain will
grow enough to make it worthwhile for farmers to sell to the high
street.

Meanwhile, the Duke of York yesterday publicly backed Mr Brown and
said that he hoped he would retain the agriculture portfolio after Tony
Blair's imminent Cabinet reshuffle.
At the Royal Show at Stoneleigh, Warwickshire, the Duke told him: "You
follow an illustrious line of agriculture ministers. They change on
average every two years. We are hoping that you will stay on a bit
longer."

Mr Brown thanked the Duke, saying: "Agricultural ministers do not last
long. I hope I can be the exception and do the job next year."

Beef exports `to resume next month

Opinion (webmaster):
Apparently Britain has declined to use any of newly validated tests now available to detect preclinical BSE. Random testing of slaughterhouse cattle has never been allowed at any time during the epidemic. BSE may have become endemic in the same sense of scrapie -- no reason has ever been advanced for why it wouldn't. The mystery is not why Britain wants to resume exports but why Europe would accept them without common-sense testing. How is EU self-interest is protected with this?

Perhaps if the EU accept BSE-tainted beef, then Britain cannot refuse dioxin-tainted animal products.
A date for the resumption of British beef exports, banned in the wake of the mad cow disease crisis, is expected to be set by the European Commission next week, according to reports today. The three-year worldwide ban on British beef exports, imposed in March 1996 after links were identified between BSE and a human form of the brain disease, is expected to be formally lifted on August 1.

The embargo has cost the UK agricultural industry more than 1.5 billion. It is understood that EU Agriculture Commissioner Franz Fischler will next Wednesday give the go-ahead for British beef to go back on the world market from next month. The Meat and Livestock Commission already has well-developed plans for a worldwide marketing campaign to promote British beef and is expected to particularly focus on quality breeds such as Aberdeen Angus. The decision to end the ban was taken last December but officials have been waiting for inspections of British abattoirs and processing plants before a date could be set for exports to resume.

MLC spokesman Ray Barrowdale said he was preparing for an announcement when the EU's scientific committee meets next week. "We are expecting a date to be set but we don't know when it will be, although August 1 looks like the favourite." Mr Barrowdale said EU veterinary inspectors appeared happy with the tracing schemes that British farmers introduced in the wake of the crisis, including the database for cattle passports and increased monitoring of abattoir conditions.

He said: "As far as we are aware the inspectors found no problems with the plants they visited. Initially only four or five plants will begin exporting beef, as they have to be dedicated purely to exports and it is obviously a commercial decision." The MLC would launch a high profile campaign aimed at recapturing the confidence of European suppliers and hoped this would filter down to consumers.

But he agreed that markets would not return overnight. "We are not kidding ourselves and know that it will take time. But this is the final piece in the jigsaw and will give consumers here and abroad the extra confidence to buy British beef. "Over the period of the ban we have kept in contact with suppliers around the world and there is still a lot of goodwill out there. Now we need to convert that into sales."

The MLC realises that initial exports will focus on the quality end of the market, with restaurants and caterers on the continent expected to begin reordering Scottish beef, which was extremely popular before March 1996. Mr Barrowdale said the MLC estimated that just 5,000 tonnes of British beef would be exported in the first year after the ban was lifted, compared to 246,000 tonnes - worth 520 million - in 1995.

The biggest markets for British beef in Europe have been France, Italy and Holland, with South Africa the biggest outside the EU. A spokesman for the National Farmers' Union added: "We are delighted that it looks like the ban will finally be lifted and we are working to ensure that British beef farmers can get their product back on the market."

Ben Gill, president of the National Farmers' Union, said that he was negotiating for one of the first shipments of British beef to leave the UK once the ban was finally lifted to be sent to feed troops in Kosovo. Speaking from Brussels he said: "Obviously there is still a lot of work to do but setting the date is a first step." He added: "I will be talking to the Ministry of Defence to ensure that our British soldiers in Kosovo will be getting fed British beef as soon as the ban is lifted. "From my information the date looks like being August 1 but it could be even sooner.

But it is about time. "It will be an enormous morale boost to the British agricultural industry which has felt so unfairly isolated and is also important as the first step to rebuilding confidence in British beef. "I have no doubt that we can regain markets as British beef quality is second to none."

France reports 2 new cases; 1999 total now 14

COMTEX Newswire Mon, Jul 12, 1999 By Christopher Mc Carthy, Bridge

Authorities have discovered 2 new cases of bovine spongiform encephalopathy (BSE), or "mad
cow" disease in the north-east and north-west regions of France, the
French Agriculture Ministry said today. Since 1990, 63 cases of BSE have
been discovered in France.

The cows, born in October and September 1994,
are the 13th and 14th cases reported in 1999. According to current
regulations, the 2 herds, totaling 65 and 83 cattle, were slaughtered last
week, the Ministry said.

Cattle passports set to cost 7 pounds

Thu, Jul 8, 1999 By Martin Evans, Parliamentary Staff, PA News

Cattle passports will cost an estimated 7 each when the industry takes
over the cost of running the system in September, the Government disclosed
today. Interested organisations were being consulted on the level of charges
for the system which was launched in September 1998 following the BSE
crisis.

The Government agreed to fund the Cattle Tracing System during its first
year but said the industry should then take over the costs.
The cattle passports provide a full history of herds in an attempt to
restore order in the beef industry.

Deputy Agriculture Minister Jeff Rooker said in a Commons written reply
more than two million cattle passports had been issued by July 5.
Around 90% were issued within three working days of the application
being received. "In addition, ... 221,506 calls from farmers have been handled by the
British Cattle Movement Service call centre since it opened in July 1998."
He estimated up to three million passports would be issued annually.

EU To Lift British Beef Ban in August 1999

11 July 99 The Associated Press By Peter James Spielmann

BRUSSELS, Belgium - A three-year ban on British beef imports, imposed
after an outbreak of ``mad cow'' disease, is to be lifted Aug. 1, the
European Union's executive body has announced.
Spokesman Gerard Kiely said the European Commission probably will make the
decision official Wednesday after a veterinary committee from member states
gives its expected approval. EU agriculture ministers voted to lift the ban
last November after British beef was deemed safe, but no date was initially
set.

Britain will be allowed to resume the vast majority of its exports, with
restrictions being lifted on deboned meat from cattle 6 to 30 months old and
with verifiable origins.
The ban was imposed in March 1996 following an outbreak in Britain of ``mad
cow'' disease, or bovine spongiform encephalopathy, and after medical
researchers cited evidence of a link between the disease and the fatal human
brain ailment, Creutzfeldt-Jacob disease.

British beef exports totaled 246,000 metric tons in 1995. The British cattle
industry estimates it has lost $2.37 billion in business during the export
ban.

Portugal is the only other European country still forbidden to export beef,
a ban that was extended by the EC last week until August 2000. Portugal has
complained that the ban is discriminatory.
The European Commission runs the day-to-day affairs of the 15-nation union,
proposes EU law and enforces its implementation across Europe.

The Spanish Ministry of Health has angered the Spanish cattle industry by
banning the sale of veal chops, intestines, and nervous tissue on May 15
from cattle imported from European Union (EU) countries that have had cases
of bovine spongiform encephalopathy (BSE).

On June 28, slaughterhouse workers from several Spanish regions went on an
indefinite strike in protest at the ban which will force them to separate
and destroy veal-calf spinal columns making it almost impossible for them
to make veal chops. Removal of such tissues may represent an average loss
of US$350 per animal--Spain imports 750 000 calves each year for this food
product.

Spain launches a food standards agency

A National Agency for Food Safety has been set up announced the Spanish
government on June 29. The government has been aware of public anxiety over
issues such as the Belgian dioxin crisis. The
Agency will coordinate regional food-safety administrations, provide
national scientific advice, and will evaluate and control each stage of
food production in Spain.

Farmers' trade-unions have criticised the ban, saying it was announced
without warning. A spokesperson for the National Association of Bovine Meat
Producers has said that the measure will probably paralyse a lot of
slaughterhouses and quartering facilities because of the time wasted
carrying out the spine separation procedure.

Meanwhile, the European Commission is considering legal proceedings against
the Ministry of Health because it seems that Spain did not notify Brussels
of its decision. However, head of the Public Health Department of the
Basque government, Luis Gonzalez de Galdeano, said the correct measure has
been taken since "Spain has been free from BSE thus far".

But the director of the Basque government farming department, Asier Albizu,
criticised the ban saying that "to take such a measure suddenly and without
giving explanation has no sense". Albizu noted that 50km away in Hendaya,
France, slaughterhouses will continue the same practices and continue to
sell veal chops.

Major probe into `toxic' breast milk launched

Sun, Jul 11, 1999 By Martha Linden, PA News

A major scientific study into the extent to which breast milk from British mothers is contaminated with poisonous chemicals was being prepared today. About 1,000 mothers are to be recruited from the Yorkshire area to take part in research led by Leeds University into toxic chemicals such as dioxins and PCBs in breast milk. The study comes after a Whitehall committee of independent scientists examined the findings of an investigation carried out three years ago into dioxins in breast milk.

The Committee on Toxicology ruled that the research by the Ministry of Agriculture, Fisheries and Food showed low but significant levels of dioxin in breast milk. The amounts, if calculated over a lifetime, did not present a problem. A MAFF spokesman said: "The levels of dioxin were significant but in view of the suggestions from the World Health Organisation in terms of the safe limits over a lifetime it was not a cause for concern. "The total amount that we are talking about fits quite comfortably into the total amount that somebody is supposed to get, especially given that environmental exposure to this sort of thing has been falling over recent years. "But what we felt was that this was an issue that warranted further study."

The Leeds survey will attempt to collect a representative sample of breast milk to form an "archive" of milk samples reflecting social groups, diets, and number and position of children in families. News of the survey comes after it was reported that World Wide Fund for Nature is today expected to issue the findings of a study showing two-month old British infants are taking in 42 times the safe level of dioxin in breast milk. A MAFF spokesman said: "The potential, and I stress potential, risk as a result of residual contaminants is far, far outweighed by the clear and proven nutritional, health and other benefits of breastfeeding."

You say potato, they say pesticide

You're probably already eating in the brave new world of biotech foods. The popcorn at your movie house could be made from plants designed to fight off a voracious pest called the corn borer. Your baby's formula could come from soybean plants biologically transformed to withstand the herbicide Roundup. The bags of potato chips on your grocer's shelves could be sliced from spuds containing a gene that poisons Colorado potato beetles.
A dramatic increase in reliance on genetic engineering may be helping produce bumper crops, but it also is raising concern that labeling laws are weak and that too little is known about potential effects on humans and the environment.
As of last year, growers in the United States, Argentina, Canada, Australia, Mexico, Spain, France and South Africa dedicated 69.5 million acres to genetically modified crops, a 16-fold increase over just two years, according to the International Service for the Acquisition of Agri-biotech Applications, an industry institute to promote new technology.
In the United States, which represents three-fourths of the world's agricultural acreage, altered corn accounted for 40 percent of the total crop planted this year, up from 26.5 percent the year before. This year, for the first time, canola farmers planted 300,000 acres of engineered plants. Acreage devoted to a wide range of engineered crops from papaya to radicchio to squash is expanding.

In opposition, consumer groups are citing a startling Cornell University lab experiment last May in which pollen from a corn plant altered to eradicate corn borers killed Monarch butterfly larvae. If the butterfly might succumb, they reason, what might happen to humans who consume a lifelong diet of such crops? And what might happen to beneficial insects and wildlife in the environment?
The questions are pitting consumers against the agricultural industry and the U.S. government, which insist that food from genetically modified crops primarily corn, soy beans, cotton and potatoes is no different and requires no special tests or labels.

'Frankenfood'

Opposition is swelling in Europe, where the term "Frankenfood" has entered the lexicon; some major supermarket and fast-food chains have promised to rid themselves of the products; and Italy, Greece, France, Luxembourg and Denmark are blocking authorization of new genetic crops in fields and markets of European Union nations.
The resistance may be spreading.

"U.S. consumers, too, are demanding mandatory labeling and mandatory testing for environmental and human health effects," said biologist Michael Hansen, research associate at Consumers Union's Consumer Policy Institute.
The biotechnology industry, led by Monsanto, Novartis, Dow, DuPont, AgrEvo and Zeneca, calls rising criticism in Europe "hysteria and hype" from the food scare over "mad cow" disease in England and dioxin in feed, poultry, beef and butter in Belgium.

The corporations and some universities say the U.S. government is watching over our food supply, the safest in the world. There's no reason to do special tests on food or label genetically engineered ingredients because the crops are virtually unchanged from conventionally bred crops, they argue. "A tomato is a tomato is a tomato," said Brian Sansoni, senior manager of public policy communications for the Grocery Manufacturers of America, some of whose largest corporate members are biotech companies.
"A tomato that is produced conventionally or a tomato that is developed through biotechnology, the product is the same. Both products are safe."

Genetic engineering has come into practice over the last 20 years. Most commonly, bacteria, viruses, and genes from tobacco or petunia plants are inserted into soy, corn, cotton and canola so that plants can survive field applications of weed killers. Or a gene from Bacillus thuringiensis, or Bt, a bacteria found in soil, is inserted into corn, cotton andpotatoes to produce a protein toxic to pests that feed on them.

A need for labeling?

Numerous polls over the past four years have revealed consumer demand for labeling of genetically modified foods, a step the industry is fighting. The last survey by the U.S. Department of Agriculture, conducted on 604 New Jersey residents in 1995, found that 84 percent of those polled wanted mandatory labeling of engineered fruits and vegetables.

In interviews, major food companies Frito-Lay, General Mills, Gerber, Heinz, Kraft, Nabisco, Pillsbury, Procter & Gamble, Quaker and Ross Products Division of Abbott Laboratories said they accepted genetically engineered ingredients for their food products. But consumers can't go into stores or call industry trade groups to secure a list of engineered brands, complains GeneWatch, a bulletin of the Council for Responsible Genetics, a Cambridge, Mass., nonprofit organization.

"People have a right to know what they're buying in a transaction," said Philip Bereano, a professor of technical communication at the University of Washington who writes for GeneWatch. "They have a right to spend their dollars in accordance with their preferences, even if their preferences were irrational," Bereano said.

The companies have lobbied successfully against labels before the U.S. Food and Drug Administration, which regulates food additives, and the U.S. Environmental Protection Agency, which regulates pesticides.
Val Giddings, vice president for food and agriculture at the Biotechnology Industry Organization, said, "We've worked for a long time to come up with a labeling policy that we know will convey useful information about nutrition and health. "For the government to require labeling (of genetically engineered products) would be to suggest a safety or health difference where there isn't one. There's no good reason to do it."

Gathering and providing a list of altered foods would be impractical, said Sansoni of the Grocery Manufacturers. "The list would be too long," Sansoni said. "About 25 percent of corn, 38 percent of soybeans, 35 percent of canola and 45 percent of cotton crops are derived from biotechnology."
"In the U.S., companies aren't really set up for segregation," Sansoni said. "It would be enormously expensive. The products are mixed in with products that contain ingredients that are not genetically enhanced."

In May 1992, then-Vice President Dan Quayle announced a long-awaited U.S. policy: Genetically engineered crops, judged by government scientists to be no different from plants bred traditionally, would need no extra government scrutiny. The processed food made from the crops wouldn't require labeling or special testing before going to market.

The FDA doesn't test bio-engineered foods before they go to the public, deeming them not "materially" different from other foods. If the foods later pose a risk to public health, the FDA has the authority to remove them from the marketplace. FDA representatives say they would require labeling only if genes from plants that could cause allergies were engineered into a crop.
"The only way to be assured of not consuming genetically engineered food is to only buy food that is certified with an organic labeling," Bereano said.

Potato listed as a pesticide

Some foods, such as Monsanto's New Leaf potato, are actually registered with the EPA as a pesticide every part of it can kill a Colorado potato beetle. As a result, it comes under the regulatory jurisdiction of the EPA, not the Food and Drug Administration.

Kathleen Knox, deputy director of EPA's Biopesticides and Pollution Prevention Division, said the agency "regulates biopesticides as we regulate other pesticides. We do the equivalent that we do for any other pesticides."
In the case of the bacterium Bt, she said, "We believe it's safe in the food supply. We certainly have looked at many factors, and we make sure things are adequately tested, particularly the things we've registered so far. We've collected data, done risk assessments. We continue to monitor what's going on in the field."

Hansen, of the Consumer Policy Institute, said neither the EPA, the FDA nor the USDA required adequate testing. "If you look at the FDA requirements carefully, you'll see that the industry is on the honor system," Hansen said. "There is no mandatory safety testing of food before it's put on the market. Bt crops aren't even regulated by the FDA. Legally, those crops aren't considered food but pesticides, which are regulated by the EPA."
But the EPA doesn't test the safety of the engineered plant itself the potato with Bt in it, Hansen said. The EPA tests Bt in isolation. Further, the studies are flawed because they don't use Bt toxin produced by the plant but use the Bt toxin produced by engineered bacteria, which is different, he said.

While proponents of genetic crop engineering say the selection of genes is precise, critics say inserting a gene into a living cell is highly imprecise, with no control over where in the DNA the new gene is implanted. This can disrupt the natural genetic information encoded in the DNA of a new plant, leading to unexpected and unwanted effects, including potentially increasing toxin levels, changing nutritional values or introducing allergy-causing properties.

"When you insert a gene into a DNA by using genetic modification, you have no idea where the gene goes it's absolutely a shot in the dark," said molecular biologist John Fagan, founder of Genetic ID Inc., a Fairfield, Iowa, laboratory. The lab tests foods for the presence of genetically engineered materials. His clients include many large food retailers in Europe that have promised to start weeding out modified foods.

"These random mutagenic events can cause plants or crops to produce new toxins, new allergens or they can reduce the nutritional value of the food," Fagan said. Because the toxins or other properties may be new, he said, there's no way to predict their effects. "The only way to detect them will be actual feeding studies with paid human volunteers," he said. "They do this for drugs and new food additives, and yet these tests are not required of the agricultural biotechnology industry.

The FDA's own scientists have expressed serious concerns about this." New studies are raising questions, said Fagan, who for nearly 20 years, including seven years at the National Institutes of Health, has used genetic engineering techniques in basic research.

A preliminary study by the Center for Ethics and Toxics in the North Coast town of Gualala, published July 1 in the Journal of Medicinal Food, found that soybeans altered to withstand Roundup might be nutritionally inferior to conventional soybeans. The altered soybeans contain reduced levels of phytoestrogens, substances in plants that are credited with guarding against heart disease and cancer, among other health benefits.

In a 1998 preliminary study at Rowett Research Institute in Aberdeen, Scotland, rats fed genetically modified potatoes suffered damaged organs and stunted growth compared with rats eating normal potatoes.
A review panel formed by the Royal Society, a scientific body, challenged the research. Researcher Arpad Pusztai has said the panel hadn't looked at his recent data.

Are there environmental effects?

Critics complain there is little study on the environmental effects of genetically altered plants. The Cornell University experiment was an exception.
"That tiny little Monarch butterfly experiment, one that any high school student could have done? Well, those studies weren't being done," said Ignacio Chapela, assistant professor in the Department of Environmental Science, Policy and Management at UC-Berkeley.
Researchers report that two beneficial insects that attack pests ladybugs and green lacewings also might be victims of the crops designed to kill the corn borer and the Colorado potato beetle.
The Swiss Federal Research Station for Agroecology and Agriculture found in 1998 that green lacewings suffered a two-thirds increase in death rate when they fed on army worms eating corn engineered to contain a bacteria toxic to crop pests.
The Scottish Crop Research Institute in Dundee concluded the same year that female ladybugs that ate aphids that had fed on genetically modified potatoes laid fewer eggs and lived only half as long as the average ladybugs.
In May, the British Medical Association warned that it was far too early to know whether genetically modified foods were safe. It opposed rapid introduction of the crops into Great Britain and advised a ban on imported foods if they weren't clearly labeled.

"We should follow the old public health tradition now being used in Europe, called the precautionary principle, which embodies the age-old wisdom of 'look before you leap,' " said Bereano, of GeneWatch. "If there's a lot of uncertainty, the prudent course of action is to assess the product before sending it out for mass consumption.
"The burden of proof should rest on the proponent of the new technology."